Factsheet for Manufacturers of Medical Devices and In-Vitro Diagnostic

1. Factsheet for Manufacturers of Medical Devices
2. Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices

Medical Devices Regulation (2017/745/EU)

The new Medical Devices Regulation (2017/745/EU) (MDR) and the In-Vitro Diagnostic Medical Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market. Transitional periods are planned to smooth the application of the new Regulations. However, you should bear in mind that consultants, in-house professionals, and Notified Bodies will all get busier as the deadline draws closer.

Medical Devices Regulation (MDR) background The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD). The MDR was published in May 2017, marking the start of a three-year period of transition from the MDD and the AIMDD. During the transitional period the MDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the MDR. The transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. From that date the MDR will apply fully.

To avoid market disruption and allow a smooth transition from the Directives to the Regulation, several transitional provisions are in place (Article 120). Some devices with certificates issued under the Directives (AIMDD/MDD certificates) may continue to be placed on the market until 27 May 2024 , and made available until 27 May 2025. During the transition phase, products certified under the Directives and products certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place.

In-Vitro Diagnostic Medical Regulation (2017/746/EU)

The IVDR will replace the existing In-Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The IVDR was published in May 2017, marking the start of a five-year period of transition from the IVDD.

During the transitional period the IVDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the IVDR.

The transitional period will end on 26 May 2022, the “Date of Application” (DoA) of the Regulation. From that point the IVDR will apply fully.

To avoid market disruption and allow a smooth transition from the Directive to the Regulation, several transitional provisions are in place (Article 110). During the transition phase, products certified under the Directive and products certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place.

EC 2018

	Factsheet for Manifacturers of Medical Devices.pdf	Abbonati Marcatura CE	10
	Factsheet for Manifacturers of In-Vitro Diagnostic.pdf	Abbonati Marcatura CE	8